Our Cleanroom Certification Services

ISO Class 1-9 cleanrooms are recommended per ISO 14644 to be certified at a minimum time interval of once per year. Certified technicians follow ISO procedural standards. ICCAT perform Cleanroom Certification and Testing for Cleanrooms, Fan Filter Units, Biological Safety Cabinets (BSC), Fumehoods, Laminar Flowbenches, Isolators, and mini environments.

Trust your cleanroom to the experts in the business, contact us, and speak to our engineer for a consultation on how ACM can best help with your cleanroom certification and testing needs.

Particle Counting

  • Purpose: To Measure the Particle Levels in the Cleanroom in Order to Classify the Room.
  • Instrumentation: Calibration Documents on Equipment Used for Certification Are Attached to the Report.
  • Procedures: Divide the Cleanroom work zone into grids of equal proportion and plot the sample locations according to room class and standard used to classify the cleanroom. Place the particle counter probe and take samples perpendicular to the airflow at working height. Record and report data for each considered particle size for the designated classification.
  • Acceptance: The average particle concentration at each sample location should fall at or below the class limit, and the mean of these averages should fall at or below the class limit. Under certain circumstances, a 95% confidence limit is computed.

HEPA Filter Leak Test with Ambient Air

  • Purpose: To verify that all HEPA filters, filter housing, and mounting frames located in the Cleanroom are free from leakage when operating at the manufacturer-recommended airflow velocities.
  • Instrumentation: Calibration documents for equipment used for testing will be attached to the certification report.
  • Procedures: Using the particle counter probe, scan the entire downstream side of HEPA filters, mounting frames and filter housing. The unit is scanned at a traverse rate of not more than two (2) inches per second in slightly overlapping strokes. The probe shall be more than one (1) inch in area. Report all results on the test report.
  • Acceptance: Ambient air should not exceed 0.01 percent of the upstream concentration at any point. However, upstream ambient air may be too clean to leak test within a reasonable amount of time, in this case an aerosol may be used. Filter integrity requirements are a matter of agreement between buyer and seller.

HEPA Filter Aerosol Leak Test Using PAO or Dry Test Spheres

  • Purpose: To verify that all HEPA filters, filter housing, and mounting frames located in the cleanroom are free from leakage when operating at the manufacturer's recommended airflow velocities.
  • Instrumentation: ATI Photometer and ATI Aerosol Generator. Calibration documents for equipment used for testing will be included in the certification reports.
  • Procedures: The challenge is generated using PAO or Dry Test Spheres. A photometer is used. The entire downstream side of HEPA filters, mounting frames, and filter housing is scanned 1″ (2.5 cm), whenever possible, at a traverse rate of not more than two (2) inches per second in slightly overlapping strokes. The probe should be not more than one (1) inch in diameter and have a sample rate of at least one (1) cubic foot per minute. Report all results on the test report. Reference IES-RP-006.2 and ACM-9000-PAO.01
  • Acceptance: Aerosol penetration (PAO/DOP) should not exceed 0.010 percent of the upstream concentration at any point; however, filter integrity requirements are a matter of agreement between the buyer and seller. Reference IES-RP-006.2

HEPA Filter Air Flow Velocity

  • Purpose: To determine the volume of air delivered through each HEPA filter and to calculate the average airflow, uniformity range, and room air exchange rate within the Cleanroom.
  • Instrumentation: Velometer, Balometer, Anemometer - Calibration documents for equipment used for testing will be included in the certification reports.
  • Procedures:
  • Unidirectional Air Flow Test: Divide the work zone entrance into a grid of 2' x 2' sections. Using the instrument, test 12" below filters.
  • Non-unidirectional Air Flow Test: Divide the filter into 2' x2' sections. Orient the instrument perpendicular to the velocity flow vector being measured. The probe should be positioned at a distance of no more than 6" (15 cm) from the filter face.
  • Airflow volume test using instrument: Measure and record the linear flow rate and average the result(s). Multiply the average velocity by the effective filter area to arrive at the total cubic volume.
  • Airflow volume test when using a Balometer: The flow hood opening is placed completely over the filter or diffuser, seating the face of the hood against a flat surface to prevent air bypass and inaccurate readings. Measure and record the flow rate in cubic volume per minute for each filter or diffuser.
  • Acceptance: The average airflow velocity or total airflow volume for the cleanroom of the clean zone should be within ± of the value specified for the cleanroom or clean zone or within other tolerance limits agreed upon by the buyer and seller.

Temperature & Humidity

Temperature

  • Purpose: To verify the capability of the Cleanroom air handling equipment to maintain temperature within design specifications.
  • Instrumentation: Hygro-Thermometer - Calibration documents for equipment used in testing are included in the certification report.
  • Procedures: This test is recommended for areas where temperature and moisture levels are primarily controlled for purposes of worker comfort rather than process or equipment requirements. When processes require strict temperature control, a more comprehensive test is performed.
  • Allow room to operate for 24 hours before testing.
  • Measure the temperature at a minimum of one location for each temperature control zone.
  • Place each sensor at the designated location at work-level height.
  • Record the time and temperature readings at each location.
  • Acceptance: Temperature and uniformity requirements are a matter of agreement between the buyer and the seller.

Humidity

  • Purpose: To verify that the system humidity control of the Cleanroom is working at the acceptance level. Humidity control is necessary to:
  • Prevent corrosion and/or oxidation.
  • Prevent condensation on work surfaces.
  • Reduce static electricity.
  • Provide personnel comfort.
  • Prevent product contamination.
  • Compensate for hygroscopic materials.
  • Control microbial growth.
  • Instrumentation: Hygro-Thermometer – Calibration documents for equipment used for testing are included in the certification report.
  • Procedures: Divide the Cleanroom work zone into grids of equal proportion. Place the humidity probe into the center of each test grid and record the humidity.
  • Acceptance: Humidity and uniformity requirements are a matter of agreement between the buyer and seller.

Room Pressure Differential

  • Purpose: To verify that a differential pressure should be maintained between the rooms sufficient to assure airflow outward progressively from the cleanest spaces to the least clean during normal operation and during periods of temporary upsets in air balance, as when a door connecting two (2) rooms is suddenly opened.
  • Instrumentation: Manometer - Calibration documents for equipment used in testing are included in the certification report.
  • Procedures: With all doors closed and the air handling systems operating at design capacity, measure the pressure differential (in inches water gauge) between the Cleanroom and surrounding areas. Record the direction of pressurization and differential pressure in inches water gauge and report all data in the test report.
  • Acceptance: Pressurization and uniformity requirements are a matter of agreement between buyer and seller.

Molecular Air & Surface Testing

  • Purpose: To analyze and identify the presence and distribution of microorganisms, particles, and contaminants in the air and on surfaces within a controlled environment
  • Instrumentation: Microbial air samplers, surface swabs, or particle counters.
  • Procedure:
    1. Prepare and calibrate sampling equipment.
    2. Identify sampling locations based on airflow and contamination.
    3. Collect air and surface samples following proper techniques.
    4. Label and transport samples for analysis.
    5. Analyze samples for microbial content and contamination levels.
    6. Document procedures, results, and any corrective actions.
  • Acceptance: Room recovery requirements are a matter of agreement between the buyer and the seller.

Light Testing

  • Purpose: The lighting level and uniformity tests verify that installed lighting levels and uniformity meet the specified requirements.
  • Instrumentation: A portable photoelectric illumination meter - Calibration documents for equipment used in testing are included in the certification report.
  • Procedures:
    1. A measurement grid shall be determined and positioned to cover a representative area of the working plane. The report shall note any obstructions above the working plane, away from columns, tall pieces of equipment, filing cabinets, etc.
    2. Determine the number of samples by dividing the area into 0.6 m (2 foot) squares, reading each square, and averaging.
    3. Take one measurement per sample location and record the measurements by hand and in the unit of measurement of foot-candles
    4. Follow the OEM Light meter manual to determine the unit of measurement and reading multiplication factor (if applicable)
    5. Report data as either foot candles or lux as a unit of measurement
  • Acceptance: Lighting levels and uniformity requirements are a matter of agreement between the buyer and the seller.

Vibration Testing

  • Purpose: To assess and measure the levels of vibration within a controlled environment
  • Instrumentation: Accelerometer
  • Procedure: 1. Place and secure the accelerometer at various locations.
    2. Record vibration levels and analyze the data.
    3. Take corrective actions if necessary.
    4. Document all procedures and findings for future reference
  • Acceptance: Vibration requirements are a matter of agreement between the buyer and the seller.

Sound Testing

  • Purpose: The purpose of the sound level tests is to verify that ambient sound levels meet specified requirements.
  • Instrumentation: A Sound Level Meter shall be utilized to perform all sound level testing
  • Procedures:
    1. The sound criteria established for a project shall be as specified in the contract documents or as agreed to between the buyer and seller
    2. To determine the number of samples, if actual locations are not identified on the contract documents, a grid shall be prepared so that the minimum locations meet the following requirements: a minimum of 2 measurements per cleanroom or clean zone space and at least one measurement per 36 m2 (400 f2).
    3. Take one measurement per sample location and record it by hand in the unit of the requested sound criteria.
  • Acceptance: Sound levels and uniformity requirements are a matter of agreement between the buyer and the seller.

Room Recovery

  • Purpose: To assess the time and efficiency required for the cleanroom environment to return to specified cleanliness levels after a contamination event or disruption.
  • Instrumentation: Aerosol Generator
  • Procedure:
    1. Contaminate the room with particles using the aerosol generator or the specified method.
    2. Monitor and record the time it takes for the cleanroom environment to return to the specified cleanliness levels after the contamination event.
    3. Assess the efficiency of the room recovery process based on the set cleanliness standards.
    4. Document the room recovery process and findings for future reference and compliance purposes.
  • Acceptance: Room recovery requirements are a matter of agreement between the buyer and the seller.

Air Laminarity Visualization Testing

  • Purpose: To observe and assess the airflow patterns and laminarity within the controlled environment
  • Instrumentation: Aerosol Generator
  • Procedures:
    1. Place the aerosol generator in the designated area within the cleanroom.
    2. Activate the aerosol generator to produce a controlled release of smoke or aerosol particles into the air.
    3. Observe the movement and dispersal of the smoke to visualize the airflow patterns within the cleanroom.
    4. Take note of any areas where the smoke accumulates or flows irregularly, indicating potential airflow disturbances.
    5. Record the observations and compare them with the expected laminar airflow pattern requirements.
    6. Make any necessary adjustments to the cleanroom's ventilation system based on the findings.
    7. Document the results and any corrective actions taken for future reference and compliance purposes.
  • Acceptance: Smoke Visual Testing is a matter of agreement between the buyer and the seller.

ESD Surface Conductivity Test

  • Purpose: To ensure the surface conductivity levels are within the specified requirements
  • Instrumentation: Surface Resistance KIT
  • Procedure:
    1. Use the DESCO Surface Resistance KIT or similar instrumentation to conduct the test.
    2. Follow the manufacturer's instructions to set up the equipment.
    3. Place the testing probe on the surface and record the resistance measurements.
    4. Repeat the measurements at different locations within the cleanroom to ensure uniform surface conductivity.
    5. Document the measurements and compare them against the specified surface conductivity requirements.
  • Acceptance: Acceptance requirements are a matter of agreement between the buyer and the seller.

Validation Testing

Step 1 - Installation and Operational Qualification.

  • Installation Qualification (IQ)
    Verifies that the cleanroom has been installed according to the manufacturer's specifications, including critical parameters like HEPA filtration leak testing and velocities, lighting, sound, vibration, molecular, temperature and humidity testing, room pressure differential testing, air handler unit operation, and construction materials. All IQ testing is performed prior to building certification and acceptance between the owner and the contractor.
  • Operational Qualification (OQ)
    Ensures that the cleanroom consistently operates within its critical parameters, such as air purity, temperature, and humidity after the process equipment has been introduced into the cleanroom. Environmental sampling for GMP quality baselines may be started during OQ.

Step 2 – Performance Qualification (PQ)

  • During the (PQ) stage of process validation, the process design is evaluated to determine if it is capable of reproducible manufacture. Testing and sampling demonstrate that the cleanroom will perform as expected under simulated real-world process design conditions, such as controlling pressure over time and ensuring that air moves in the correct direction, sampling for environmental bioburden for consistency and assurance under the process design sampling plan verifying the facility maintenance procedures.
  • The sampling plan, including sampling points, the number of samples, and the frequency of sampling for each unit of operation are implemented. The number of samples is planned to be adequate to provide sufficient statistical confidence of quality. Sampling during this stage should be more extensive than is typical during routine production.

Stage 3 ― Continued Process Verification

  • We recommend continued monitoring and sampling of process parameters and quality attributes at the level established during the PQ stage until sufficient data are available to generate significant variability estimates. These estimates can provide the basis for establishing levels and frequency of routine sampling and monitoring for the particular product and process. Monitoring can then be adjusted to a statistically appropriate and representative level. Process variability should be periodically assessed and monitoring adjusted accordingly.
  • Maintenance of the facility, utilities, and equipment is another important aspect of ensuring that a process remains in control. Once established, qualification status must be maintained through routine monitoring, maintenance, and calibration procedures and schedules (21 CFR part 211)

As-Built, At Rest, and In Operation

Construction Approval (As-Built)

A systematic range of inspections, adjustments, measurements, and tests shall be carried out to ensure that each part of the installation complies with the design requirements. Prior to carrying out any inspection, test, or measurement procedure, running systems should be allowed time to reach stability; this period of time should be agreed upon in advance. Tests should be of sufficient duration to demonstrate consistent performance. (ISO 14644-4). *Prior to the fitting of filters and after cleaning has been completed, all ducts, walls, ceilings, floors, and installed fittings should be cleaned to remove contamination that could prejudice the classification of the cleanroom. Following the cleaning, the final filters should be fitted and the commissioning tests conducted to demonstrate compliance. * Particle counts of the construction zone may be taken to determine if the air is clean enough to install the filters.

All air filtration equipment installed in an installation should allow for leak-testing of the final filters and integrity testing of the seals between the filter and mounting arrangements. Consideration should be given to the materials used for such testing to ensure that materials themselves do not become contaminated or cause contamination.

A check should be carried out to ensure that the construction of the installation complies with the design. The check should include at least the following items:

  • Completeness of the installation.
  • Interfaces with other suppliers.
  • Correct function of utilities and auxiliary equipment.
  • Calibration of all control, monitoring, warning, and alarm systems.
  • Fitting and in-situ testing of final filters.
  • Proving the reserve capacity of the air treatment system.
  • Testing enclosure for leakage.
  • Confirming that the proportion of recirculation to make-up aire complies with the design specification.
  • Surface cleanliness and suitability of the installation.
  • Spare parts package.

Functional Approval (At Rest)

A series of tests and measurements shall be carried out to determine that all parts of the installation operate together to achieve the required conditions in the “as-built” or “at rest” states. The tests and measurements are a matter of agreement between the buyer and seller.

After having completed the checks and approvals at least the following functional tests should be performed:

  • Determine clean zone segregation.
  • Measure and record contamination control recovery time.
  • Determine the ability to maintain temperature and relative humidity requirements.
  • Determine airborne particulate cleanliness class.
  • Where appropriate, determine particulate cleanliness class.
  • Where appropriate, determine particulate surface cleanliness and microbiological contamination levels.
  • Determine light and noise levels.
  • Demonstrate and record airflow patterns and air change rate if necessary.

Operational Approval (In Operation)

A series of tests and measurements shall be carried out to determine that the complete installation achieves the required “operational” performance with the specified process or activity functioning and with the specified number of personnel present working in the agreed manner.

  • Certain of the previous tests could be repeated to determine compliance with the operational conditions, namely.
  • Confirm clean zone segregation regime.
  • Determine the ability to maintain temperature and relative humidity.
  • Determine airborne particulate cleanliness class.
  • Where appropriate, determine particulate surface cleanliness and microbiological contamination levels.
  • Check the completeness of documentation.

For compliance-related issues, refer to ISO14644-2. For microbiological-related issues, refer to ISO 14698-1, ISO 14698-2; for testing-related issues and for operational-related issues, refer to other relevant parts of the ISO 14644-4 standard.

Environmental Monitoring

  • Viable Air and Surface Sampling With Total Numerology, Gram Stain, Gross Morphology & Species Identification
  • Purpose: To monitor the integrity of the disinfecting program.
  • Instrumentation: Air Sampler - Calibration documents for equipment used in testing are included in the certification report. RCS agar strips – Quality Control documents for strips used in testing are included in the certification report. Contact plates – Quality Control documents for plates used in testing are included in the certification report.
  • Procedures: Use aseptic techniques for both RCS sampling and Contact Plates tests. Take one contact plate sample and one RCS sample at each location. Label and record all sample strips and plates. Incubate the strips and plates at 30-35 degrees Celsius (by request, numeration at 22 degrees Celsius may be added). Count the total recoverable aerobic bioburden as CFUs per sample macroscopically. Microscopically identify and report all data in the test report. RCS and Contact plates’ counts are averaged (if more than one sample per location, by request) and reported by the CFUs. Each count is enumerated by the following formulas. CFU/Liter = Colonies on Agar Strip 100 x Sampling Time (Minutes) (“100” = Liters of air taken per minute) CFU/ft3 = Colonies on Agar Strip x0.708 Sampling Time (minutes)
  • Acceptance: Agreed upon between buyer and seller.

HEPA and ULPA Filter Repair and Replacement

  • Filter Leak Repair
  • Filter Replacement

Laminar Flow Hood Testing

  • Purpose: To provide a clean work environment by directing a steady stream of HEPA or ULPA filtered air over the work area.
  • Instrumentation: Particle Counter, Micromanometer, Photometer - The certification report will include calibration documents for the equipment used for testing.
  • Procedure: The particle counter/photometer probe and aerosol generator will help determine a leak-free hood. Introduce the aerosol upstream of the filter, scan the entire downstream side of HEPA filters, mounting frames, and filter housing at a traverse rate of not more than two (2) inches per second in slightly overlapping strokes. The particle counter should also gather at least 3 samples per hood to ensure an ISO 5 environment. The micromanometer should be within 6 inches of the filter to take a velocity output reading in feet per minute.
  • Acceptance: Aerosol penetration should not exceed 0.010 percent of the upstream concentration at any point; however, filter integrity requirements are a matter of agreement between the buyer and seller. Reference IEST-RP-CC006. The average airflow velocity or the average or total airflow volume for the cleanroom or clean zone should be within ± of the value specified for the cleanroom or clean zone, or within other tolerance limits agreed upon by the buyer and seller. The average particle concentration at each sample location should fall at or below the class limit, and the mean of these averages should fall at or below the class limit. Under certain circumstances, a 95% confidence limit is computed.

Biosafety Cabinet Testing

  • Purpose: To verify that all BSC HEPA or ULPA filters, filter housing, and mounting frames are free from leakage when operating at the manufacturer-recommended airflow velocities and maintain an ISO 5 environment within the cabinet.
  • Instrumentation: Particle Counter, Photometer, Aerosol Generator, Anemometer - Calibration documents for equipment used for testing will be attached to the certification report.
  • Procedures: With an aerosol generator to challenge the BSC Filters, use the photometer probe to scan the entire downstream side of the HEPA or ULPA filters, mounting frames and filter housing at a traverse rate of not more than two (2) inches per second in slightly overlapping strokes. The probe should not be more than one (1) inch in area. Report all results on the test report. The anemometer will ensure that it follows the BSC manufacturer-recommended airflow inlet and downflow velocities. The particle counter will ensure an ISO 5 environment.
  • Acceptance: HEPA Leakage should not exceed 0.01 percent of the upstream concentration at any point. Inlet and downstream airflow velocities must be within 5+- of manufacturer specifications. The cabinet environment must not surpass an ISO 5 environment at 0.5 microns.

"The certification technicians by far surpasses the quality of work ever done here before. That they have noticed how much your group cares about what they do and how they do it. And the BIG word there is CARES. I myself want to thank your group for what they have done. Not only in the clean room but the way they had to adapt to the personnel here and our protocol."

"Support Through Difficult Times -- I just want to thank you and your crew for such a great job performed, and for supporting us during our difficult times. Great Job!"